Introducer seal assembly

ABSTRACT

A unique surgical system and method of use includes a seal assembly which is initially mountable about a surgical instrument. The surgical instrument with mounted seal assembly is thereafter positioned within a cannula assembly. The seal assembly forms a fluid tight seal within the interior of the cannula assembly while also forming a fluid tight seal about the surgical instrument. The seal assembly and the cannula assembly cooperate to permit angulation of the surgical instrument. A magnetic coupling assists in retaining the seal assembly within the cannula assembly.

BACKGROUND

1. Technical Field

The present disclosure relates to a sealing apparatus and method forfacilitating percutaneous access of a surgical instrument into a bodycavity. More particularly, the present disclosure relates to a sealapparatus for forming a fluid tight seal between a surgical instrumentand an internal passageway of an access or cannula assembly.

2. Description of the Related Art

Minimally invasive and laparoscopic procedures generally require thatany instrumentation inserted into the body is sealed, i.e., provisionsmust be made to ensure that gases and/or fluids do not enter or exit thebody through an endoscopic incision, such as, for example in surgicalprocedures where the surgical region is insufflated. For suchprocedures, access to anatomical cavities, such as the peritonealcavity, is usually accomplished by use of a system incorporating atrocar and cannula assembly. Since the cannula is in directcommunication with the interior of the peritoneal cavity, the cannulashould be adapted to maintain a fluid tight interface between theabdominal cavity and the outside atmosphere. In view of the need tomaintain the atmospheric integrity of the inner area of the cavity, aseal assembly for a cannula, which permits introduction of a wide rangeof surgical instrumentation and maintains the atmospheric integrity ofthe inner area of the cavity is desirable. In this regard, there havebeen a number of attempts in the prior art to achieve such sealingrequirements. A difficulty encountered with conventional sealassemblies, however, is the inability of accommodating the wide range ofsizes of instrumentation. In addition, angulation and/or manipulation ofinstrumentation within the cannula often present difficulties withrespect to maintaining seal integrity.

SUMMARY

Accordingly, the present disclosure provides a unique surgical systemand method of use, including a seal apparatus which is mountable about asurgical instrument. The surgical instrument with mounted seal apparatusis thereafter positioned within a cannula assembly. The seal apparatusforms a fluid tight seal within the interior of the cannula assemblywhile also forming a fluid tight seal about the surgical instrument.

In one preferred embodiment, the surgical method includes the steps ofaccessing a body cavity with a surgical portal having a longitudinalpassage extending therethrough, mounting a seal apparatus onto aninstrument shaft of a surgical instrument whereby the instrument shaftis received within an aperture of the seal apparatus with inner sealportions defining the aperture forming a substantial seal about theinstrument shaft, at least partially positioning the instrument shaftwith mounted seal apparatus within the longitudinal passage of thesurgical portal, and establishing, with the seal apparatus, asubstantial seal within the longitudinal passage of the surgical portal.Preferably, the step of establishing includes contacting the sealapparatus with interior surfaces of the surgical portal adjacent thelongitudinal passage to form the substantial seal within thelongitudinal passage.

The surgical method may further include the step of angulating theinstrument shaft within the surgical portal to cause correspondingangulations of the seal apparatus within the surgical portal.Preferably, the seal apparatus defines an arcuate outer surface portionand wherein, during the step of angulating, the arcuate outer surfaceportion traverses the interior surfaces of the surgical portal whilemaintaining the substantial seal therewith.

The surgical method may also include the step of magnetically couplingor resiliently coupling the seal apparatus with the interior surfaces ofthe surgical portal to facilitate retention of the seal apparatus withinthe surgical portal.

The surgical method may further include the step of substantiallyclosing the longitudinal passage of the surgical portal when theinstrument shaft is removed therefrom. The step of substantially closingmay include disposing a zero-closure valve within the surgical portal.The zero closure valve is adapted to substantially close in the absenceof the instrument shaft of the surgical instrument.

In another embodiment, a surgical instrument and seal system for usewith a surgical portal is provided. The system includes a surgicalinstrument adapted to perform a surgical task and having an elongatedshaft, and a seal apparatus mounted to the surgical instrument. The sealapparatus includes inner seal portions defining an aperture thereinadapted to receive the elongated shaft of the surgical instrument insubstantial sealed relation therewith. The surgical instrument and themounted seal apparatus are dimensioned and configured to be at leastpartially positionable within the surgical portal and whereby, uponpositioning, the seal apparatus is adapted to form a substantial sealwithin a longitudinal passageway of the surgical portal. The sealapparatus may define an arcuate outer surface. Preferably, the sealapparatus defines a spherical portion having the arcuate outer surface.More preferably, the seal apparatus is in the general shape of a sphere.The seal apparatus may include one of a magnetic material and aferromagnetic material.

In another alternate embodiment, a surgical kit is provided. Thesurgical kit includes a cannula and a removable seal apparatus. Thecannula includes a cannula housing and a cannula sleeve extending fromthe housing. The cannula defines a longitudinal passage extendingbetween the cannula housing and the cannula sleeve. The cannula housingdefines an inner surface adjacent the longitudinal passage within thecannula housing. The cannula sleeve is adapted to access an underlyingbody cavity insufflated with gases. The instrument is at least partiallypositionable within the cannula housing. The seal apparatus includes anouter portion defining an outer arcuate surface and an inner portiondefining an aperture for seal reception of a surgical instrument. Uponat least partial positioning of the seal apparatus within the cannulahousing, the outer arcuate surface of the seal apparatus engages theinner surface of the cannula housing in substantial sealed relationtherewith.

The surgical kit may also include a surgical instrument adapted toperform a surgical task. The surgical instrument includes an elongatedshaft where the seal apparatus is mounted on the elongated shaft.

The cannula may include a zero-closure valve for substantially sealingthe longitudinal passage of the cannula in the absence of the surgicalinstrument.

Magnetic coupling means for facilitating retention of the seal apparatuswithin the cannula housing may be provided. One of the seal apparatusand the cannula housing includes a magnetic element and wherein theother of the seal apparatus and the cannula housing includes aferromagnetic material. The magnetic element and the ferromagneticmaterial cooperate to facilitate retention of the seal apparatus withinthe cannula housing. Alternatively, resilient coupling means may beprovided for facilitating retention of the seal apparatus within thecannula housing.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the present disclosure will become morereadily apparent and will be better understood by referring to thefollowing detailed description of preferred embodiments, which aredescribed hereinbelow with reference to the drawings wherein:

FIG. 1 is a perspective view with parts separated of the surgical systemin accordance with the principles of the present disclosure,illustrating the seal assembly, cannula assembly and surgicalinstrument;

FIG. 2 is an enlarged side cross-sectional view of the surgical systemin accordance with the present disclosure illustrating the seal assemblypositioned about the surgical instrument and mounted within the cannulaassembly;

FIG. 3 is an enlarged side cross-sectional view similar to the view ofFIG. 2 illustrating an alternate embodiment of the seal assembly; and

FIG. 4 is an enlarged side cross-sectional view of the surgical systemin accordance with the present disclosure illustrating angulation of thesurgical instrument and corresponding movement of the seal assembly;

FIG. 5 is an enlarged side cross-sectional view of an alternateembodiment of a surgical system in accordance with the presentdisclosure illustrating the seal assembly prior to mounting within thecannula assembly; and

FIG. 6 is an enlarged side cross-sectional view in accordance with thealternate embodiment of FIG. 5 illustrating the seal assembly mountedwithin the resilient coupling of the cannula assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The surgical system of the present disclosure provides a substantialseal between a body cavity of a patient and the outside atmosphereduring an endoscopic or laparoscopic surgical procedure. The surgicalsystem contemplates the introduction and manipulation of endoscopic orlaparoscopic instrumentation, and maintains a fluid tight interfaceabout the instrumentation to preserve the atmospheric integrity of asurgical procedure from gas and/or fluid leakage. Examples ofinstrumentation include clip appliers, graspers, dissectors, retractors,staplers, laser probes, photographic devices, endoscopes andlaparoscopes, tubes, and the like. Several of these instruments aredisclosed in commonly assigned U.S. Pat. Nos. 6,716,232, 6,450,391,6,231,565, 6,152,872, 5,938,668, 5,913,870 and 5,860,987, the contentsof each of these disclosures being incorporated in their entiretiesherein by reference. Such instruments will be collectively referred toherein as “instruments or instrumentation”. The surgical system of thepresent disclosure is well adapted to accommodate angular manipulationof the surgical instrument. This feature desirably minimizes the entryand exit of gases and/or fluids to/from the body cavity.

In the following description, as is traditional, the term “proximal”refers to the portion of the instrument closest to the operator whilethe term “distal” refers to the portion of the instrument remote fromthe operator.

Referring now to the drawings, in which like reference numerals identifyidentical or substantially similar parts throughout the several views,FIGS. 1-2 illustrate the surgical system 10 of the present disclosure.Surgical system 10 includes seal assembly 100, cannula assembly 200 andsurgical instrument 300. Seal assembly 100 has seal element 102 with aninner portion 104 and an outer portion 106. Inner portion 104 forms aseal and defines aperture 108 which is adapted to receive surgicalinstrument 300. In one preferred embodiment, inner portion 104 isfabricated from a resilient material whereby portions of the innerportion 104 adjacent aperture 108 engage surgical instrument 300 influid tight relation. Suitable materials for inner portion 104 includeelastomeric materials such as, e.g., polyisoprene, silicone, rubber,urethane, soft urethane gel, silicon gel, etc. Preferably, the selectedmaterial has compressible characteristics to permit inner portion 104 toconform and form a substantial seal about the outer surface of theinstrument 300 during manipulation about the operative site. The innerportion 104 and/or outer portion 106 may comprise a compressible foam.It is further envisioned that inner portion 104, outer portion 106 orboth, may be a bladder or balloon filled with fluids such as water,saline, gel, etc. . . .

Outer portion 106 may comprise an elastomeric material or, in oneembodiment, include a magnetic material or a ferromagnetic metal. Inanother embodiment, outer portion 106 may be coated with a magneticcoating or a coating of a ferromagnetic material. The use of magneticmaterial and/or ferromagnetic material facilitates the establishment ofa magnetic coupling to assist in removably retaining seal assembly 100within cannula assembly 200. The magnetic coupling will be discussed ingreater detail hereinbelow. It is also envisioned that outer portion 106may be fabricated from an elastomeric material and be monolithicallyformed with inner portion 104. Inner portion 104 and outer portion 106may be fabricated from the same or different material. In certainembodiments, inner portion 104 is formed from an elastomeric materialwhereas outer portion 106 is formed from a relatively rigid polymericmaterial.

In the embodiment shown in FIG. 2, outer portion 106 is generallyspherical and has a cylindrical opening 103 in which inner portion 104is disposed. Inner portion 104 has a generally cylindrical shape formingaperture 108 for receipt of surgical instrument 300. Outer portion 106and inner portion 104 may have other shapes, such as elliptical,polygonal, partially truncated sphere or elliptoid, etc. The sphericalshape facilitates removable coupling of seal assembly 100 with cannulaassembly 200. It is also envisioned that seal element 102 may be apartial or truncated sphere as shown in FIG. 3.

With continued reference to FIGS. 1-2, outer portion 106 has an outersurface 110 which is arcuate. As to be appreciated, the arcuateconfiguration of outer surface 110 of seal element 102 permits the sealelement 102 to angulate within cannula assembly 200.

Seal assembly 100 is preferably mountable about surgical instrument 300preferably, about elongated shaft 302 of the instrument, with theelongated shaft 302 being received within aperture 108 of seal element202. Such mounting is preferably performed prior to positioning sealassembly 100 within cannula assembly 200. Once seal assembly 100 and theinstrument 300 are positioned within cannula assembly 200, seal element102 forms a substantial fluid tight seal within the internal structureof cannula assembly 200 to prevent or substantially minimize the passageof fluids through the cannula assembly.

Referring still to FIGS. 1-2, cannula assembly 200 of the surgicalsystem 10 will be described. Cannula assembly 200 is intended to accessa body cavity and permit introduction of instruments required to performthe desired surgical procedure at a remote tissue site. Cannula assembly200 is particularly adapted for use in laparoscopic surgery where theperitoneal cavity is insufflated with a suitable gas, e.g., CO₂, toraise the cavity wall from the internal organs therein. Cannula assembly200 is typically used with a trocar obturator (not shown) which is asharp pointed instrument positionable within the passageway of thecannula assembly 200. The trocar obturator is utilized to penetrate theabdominal wall and is then subsequently removed from the cannulaassembly 200 to permit introduction of the surgical instrumentationutilized to perform the procedure. In the alternative, a blunt obturatormay be used, such as, for example, in a Hasson technique. Semi blunt ordilating obturators may also be used to gain access to the abdominalcavity.

Cannula assembly 200 includes cannula sleeve 202 and cannula housing 204mounted to a proximal end of the sleeve 202. Cannula sleeve 202 definesa longitudinal axis “a” extending along the length of sleeve 202. Sleeve202 further defines an internal longitudinal passage 206 dimensioned topermit passage of surgical instrumentation. Sleeve 202 may be formed ofstainless steel or other rigid materials, including polymeric materialsthat are medical grade material, such as surgical steel, titanium,polycarbonate, etc. Sleeve 202 may be clear or opaque. The diameter ofsleeve 202 may vary, but, typically ranges from 10 to 15 mm for use withthe seal assembly 100 of the present disclosure.

In one preferred embodiment, cannula housing 204 includes twocomponents, specifically, main housing 208 which is attached to theproximal end of cannula sleeve 202 and seal housing 210. Seal housing210 may be connectable to main housing 208 through a bayonet coupling, asnap fit coupling, ultrasonic welding or any other means envisioned byone skilled in the art including, e.g., adhesive means. Alternatively,seal housing 210 and main housing 208 may be formed integrally with oneanother. Main housing 208 further includes diametrically opposed housinggrips 212 (FIG. 1) dimensioned and arranged for gripping engagement bythe fingers of the user. Although shown and described as two components,cannula housing 204 may be a single component and attached to cannulasleeve 202 by any of the aforementioned means or may incorporatemultiple components.

With reference to FIG. 3, in conjunction with FIGS. 1-2, main housing208 further includes duck bill or zero closure valve 214 which tapersdistally and inwardly to a sealed configuration as shown. Valve 214opens to permit passage of the surgical instrument 300 and closes in theabsence of the instrumentation and/or in response to the pressurizedgases communicating from the insufflated body cavity. Other zero closurevalves are also contemplated including single or multiple slit valvearrangements, trumpet valves, flapper valves, etc. Valve 214 may besecured within main housing 208 by any conventional means. In oneembodiment, main housing 208 includes internal circumferential recess216 which receives the outer peripheral flange 218 of valve 214. A valvemount 220 may be positioned to secure the flange area of valve 214within main housing 208.

Seal housing 210 has a substantially cylindrical configuration as shown.Seal housing 210 includes seal mount 222 disposed within the interior ofthe seal housing 210 concentrically arranged about longitudinal axis“a”. Seal mount 222 is adapted to support seal assembly 100 in theassembled condition of the components. Seal mount 222 has arcuatesupport surface 224 defining a concavity as shown. Support surface 224engages outer surface 110 of seal element 102. In a preferredembodiment, the configuration of arcuate support surface 224 correspondsto the configuration of outer surface 110 of seal element 102. Forexample, in one preferred embodiment, the radius of curvature of each ofarcuate support surface 224 and outer surface 110 of seal element 102are substantially equivalent. In this regard, seal element 102 is freeto swivel or angulate relative to seal mount 220. The term “angulate” isto be interpreted to include at least two types of movement, namely,rotation of seal element 102 about longitudinal axis “b” and pivotalmovement of the seal element 102 about a pivot axis “p”. FIG. 4illustrates angulation of seal element 102 during manipulation ofsurgical instrument 300.

Seal mount 222 preferably is formed of a rigid material such as a metalor polymeric material. Seal mount 222 may have a lubricious coating tofacilitate angulation of seal element 102. Similarly, outer surface 110of seal element 102 may have a lubricious coating. Alternatively, sealmount 222 may have an elastomeric layer defining arcuate support surface224. Irregardless of the materials utilized, positioning of seal element102 within seal mount 222 establishes a fluid-tight relation between theseal element 102 and support surface 224, which substantially minimizespassage of gases through cannula assembly 200 during use in alaparoscopic procedure. In one preferred embodiment, seal mount 222includes a magnetic material or a ferromagnetic material and cooperateswith corresponding magnetic or ferromagnetic material at outer surface110 of seal element 102. In this manner, positioning of seal element 102within seal mount 222 establishes a magnetic coupling which functions toretain the seal element 102 within the seal mount 222. Preferably, thestrength of the magnetic coupling is selectively controlled to permitseal assembly 100 to angulate within seal mount 222 while maintainingthe mounted condition of the seal assembly 100 relative to cannulaassembly 200. The strength of the magnetic coupling should be selectedto allow convenient removal of seal assembly 100 from seal mount 222while retaining the seal assembly 100 during manipulation. In any of theabove, lubricating coatings may be used to further seal the cannula sealhousing 210 and facilitate manipulation of instrument.

Surgical system 10 may be part of a surgical kit incorporating at leastone seal assembly 100, corresponding cannula assembly 200 and/orsurgical instrument 300. For example, the kit could be packagedincorporating a seal assembly 100 and corresponding cannula assembly200. A plurality of seal assemblies 100 of different sizes (e.g., sealapertures with different diameters) for various instrumentation could beincorporated in the kit. Alternatively, the kit could include surgicalinstrument 300 and seal assembly 100 with the seal assembly 200 mountedabout the surgical instrument 300, either through a permanent ordetachable connection.

Referring now to FIGS. 5-6, there is illustrated another embodiment ofthe present disclosure. This embodiment of surgical system incorporatesseal assembly 100 as described hereinabove. Cannula housing 204 includesresilient coupling 226 incorporating first and second resilient legs 228which receive and mount seal assembly 100 within cannula 200. Resilientlegs 228 are adapted to flex or pivot outwardly in the direction ofdirectional arrows “p” to receive seal assembly 100 and then returnunder the influence of their natural resiliency to retain seal assembly100 within resilient coupling 226. Resilient legs 228 each include acentral arcuate portion 230 defining an arcuate configurationapproximating the general arcuate shape of the outer surface 110 of sealelement 102. In the mounted condition of seal assembly 100, the sealassembly 100 may angulate within cannula assembly 200 in the mannerdescribed in connection with the embodiment of FIGS. 1-4. The contactingsurfaces of resilient legs 228 and seal element 102 may incorporatelubricious coatings to facilitate rotational and pivotal movement of theseal assembly 100. Resilient legs 228 may comprise a polymeric materialor resilient metal such as spring steel. In other regards, seal assembly100 is utilized in the aforedescribed manner.

While the invention has been particularly shown, and described withreference to the preferred embodiments, it will be understood by thoseskilled in the art that various modifications and changes in form anddetail may be made therein without departing from the scope and spiritof the invention. Accordingly, modifications such as those suggestedabove, but not limited thereto, are to be considered within the scope ofthe invention.

1. A surgical method, which comprises: accessing a body cavity with asurgical portal having a longitudinal passage extending therethrough;mounting a seal apparatus onto an instrument shaft of a surgicalinstrument whereby the instrument shaft is received within an apertureof the seal apparatus with inner seal portions defining the apertureforming a substantial seal about the instrument shaft; at leastpartially positioning the instrument shaft with mounted seal apparatuswithin the longitudinal passage of the surgical portal; andestablishing, with the seal apparatus, a substantial seal within thelongitudinal passage of the surgical portal.
 2. The surgical methodaccording to claim 1 wherein the step of establishing includescontacting the seal apparatus with interior surfaces of the surgicalportal adjacent the longitudinal passage to form the substantial sealwithin the longitudinal passage.
 3. The surgical method according toclaim 2 including the step of angulating the instrument shaft within thesurgical portal to cause corresponding angulations of the seal apparatuswithin the surgical portal.
 4. The surgical method according to claim 3wherein the seal apparatus defines an arcuate outer surface portion andwherein, during the step of angulating, the arcuate outer surfaceportion traverses the interior surfaces of the surgical portal whilemaintaining the substantial seal therewith.
 5. The surgical methodaccording to claim 2 including the step of magnetically coupling theseal apparatus with the interior surfaces of the surgical portal.
 6. Thesurgical method according to claim 3 including the step of substantiallyclosing the longitudinal passage of the surgical portal when theinstrument shaft is removed therefrom.
 7. The surgical method accordingto claim 6 wherein the step of substantially closing includes disposinga zero-closure valve within the surgical portal, the zero closure valveadapted to substantially close in the absence of the instrument shaft ofthe surgical instrument.
 8. The surgical method according to claim 2including the step of resiliently coupling the seal apparatus with theinterior surfaces of the surgical portal.
 9. A surgical instrument andseal system for use with a surgical portal, which comprises: a surgicalinstrument adapted to perform a surgical task, the surgical instrumentincluding an elongated shaft; and a seal apparatus mounted to thesurgical instrument, the seal apparatus including inner seal portionsdefining an aperture therein adapted to receive the elongated shaft ofthe surgical instrument in substantial sealed relation therewith; thesurgical instrument and the mounted seal apparatus being dimensioned andconfigured to be at least partially positionable within the surgicalportal and whereby, upon positioning, the seal apparatus is adapted toform a substantial seal within a longitudinal passageway of the surgicalportal.
 10. The surgical system according to claim 9 wherein the sealapparatus comprises an outer member defining an arcuate outer surface.11. The surgical system according to claim 10 wherein the seal apparatusouter member is generally spherical and has an arcuate outer surface.12. The surgical system according to claim 11 wherein the seal memberincludes a seal member arranged inwardly with respect to the outermember and having the inner seal portions.
 13. The surgical systemaccording to claim 9 wherein the seal apparatus outer member comprisesone of a magnetic material and a ferromagnetic material.
 14. Thesurgical system according to claim 9, wherein the inner seal portionsslidably engage the shaft.
 15. A surgical kit, which comprises: acannula including a cannula housing and a cannula sleeve extending fromthe housing, the cannula defining a longitudinal passage extendingbetween the cannula housing and the cannula sleeve, the cannula housingdefining an inner surface adjacent the longitudinal passage within thecannula housing, the cannula sleeve adapted to access an underlying bodycavity insufflated with gases; and a removable seal apparatus at leastpartially positionable within the cannula housing, the seal apparatusincluding an outer surface and an inner surface defining an aperture forsealed reception of a surgical instrument, whereby upon at least partialpositioning of the seal apparatus within the cannula housing, the outersurface of the seal apparatus engages the inner surface of the cannulahousing in substantial sealed relation therewith.
 16. The surgical kitaccording to claim 15 including a surgical instrument adapted to performa surgical task, the surgical instrument including an elongated shaftand having the seal apparatus mounted on the elongated shaft.
 17. Thesurgical kit according to claim 15 wherein the cannula includes azero-closure valve for substantially sealing the longitudinal passage ofthe cannula in the absence of the surgical instrument.
 18. The surgicalkit according to claim 15 including magnetic coupling means forfacilitating the removable retention of the seal apparatus within thecannula housing.
 19. The surgical kit according to claim 15 includingresilient coupling means for facilitating the removable retention of theseal apparatus within the cannula housing.
 20. The surgical kitaccording to claim 15 wherein one of the seal apparatus and cannulahousing includes a magnetic element and wherein the other of the sealapparatus and the cannula housing includes a ferromagnetic material, themagnetic element and the ferromagnetic material cooperating tofacilitate removable retention of the seal apparatus within the cannulahousing.